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FDA (Drug enforcement)Recalled 2020-03-13closedclass ii

Sun Pharmaceutical Industries, Inc.: Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Ind

Is my product affected?

Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50.

  • Brand DOXYCYCLINE

Check against the official notice below — it lists the full affected range.

What happened

Sun Pharmaceutical Industries, Inc. is recalling Doxycycline Capsules, USP, 100 mg in 50-count bottles distributed nationwide in the USA. The recall affects 172,320 bottles manufactured by Ohm Laboratories Inc. in New Brunswick, New Jersey. The affected lots are: #3983720 (expiration 10/2020); #3990461, #3990464, #3990465, #3990466, #3990470 (expiration 11/2020); #AA42499, #AA42510, #AA44468, #AA44470 (expiration 04/2021); #AA55073, #AA55074, #AA55075 (expiration 05/2021); and #AA61486 (expiration 06/2021).

The doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions, which is a violation of FDA requirements. The source document does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.

Details from the source

Reason for recall: CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. Distribution: Nationwide in the USA Quantity: 172,320 bottles Lot/code info: Lot #: 3983720, Exp 10/2020; 3990461, 3990464, 3990465, 3990466, 3990470, Exp 11/2020; AA42499, AA42510, AA44468, AA44470, Exp 04/2021; AA55073, AA55074, AA55075, Exp 05/2021; AA61486, Exp 06/2021

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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